A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

Launched by UCB BIOPHARMA SRL · Oct 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a medication called certolizumab pegol (CZP) to see how well it works and how safe it is for treating children and teenagers with moderate to severe chronic plaque psoriasis. Psoriasis is a skin condition that causes red, scaly patches. The trial is open to young people aged 6 to 17 who have had psoriasis for at least three months and have significant areas of their skin affected by the condition. To qualify, participants must meet certain criteria, such as having a specific score that indicates the severity of their psoriasis.

Participants in the trial will receive the medication and will be monitored for its effects. They will have regular check-ups to assess their skin condition and overall health. This study is important because it aims to find effective treatment options for children and adolescents who struggle with this challenging skin condition. If you think your child might be eligible, it's a good idea to talk to your doctor for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
• • 1. Body Surface Area (BSA) affected by psoriasis ≥10 %
• • 2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
• • 3. Psoriasis Area and Severity Index (PASI) score is ≥12 or
• 4. PASI score is ≥10 and \<12 with at least one of the following:
• • Clinically relevant facial or scalp involvement
• • Clinically relevant genital involvement
• • Clinically relevant palm and sole involvement
• • Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
• • Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
• Exclusion Criteria:
• • Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
• • Study participant has generalized pustular or erythrodermic psoriasis (PSO)
• • Study participant has guttate PSO without plaque PSO
• • Study participant has had a primary failure to an anti-tumor necrosis factor agent
• • Study participant has had prior exposure to \>2 biologic therapies
• • Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening